Managing Quality Within the Medical Device Supply Chain

Sparta Systems

For medical device manufacturers, confidence in the quality of outsourced or offshored components or raw materials is crucial. 

Supply chain factors—such as nonconforming materials or processes—have been noted as contributing to the errors that led to a 126 percent spike in medical device recalls early in 2018.

Yet a large proportion of medical device manufacturers lack visibility into their (often complex) supply chains. 

Gaining this end-to-end quality insight—and better yet, integration—will be even more important as new EU medical device regulations go into effect this year.  

Outsourcing on the Rise 

Outsourcing in the medical device industry is here to stay, it seems.

According to Acumen Research and Consulting, outsourcing is a growing solution for medical device manufacturers looking for scalability and cost efficiency in design, assembly, and packaging.

Acumen predicts that this outsourcing market will top $190 billion within the next five years. 

But while outsourcing may deliver benefits, it also adds significant complexity to the supply chain.

Multiple suppliers increase the challenge of gaining visibility into critical quality information, but real-time (or near-real-time) access to that information is necessary for manufacturing quality managers to make proactive decisions.  

Increasing Regulatory Pressure  

With regulatory agencies creating additional compliance guidelines and demands, end-to-end insight becomes even more important.  

• European Union Medical Device Regulation (EU MDR) evaluates outsourced products for quality and conformity 
• Alteration in ISO certification 
• Adoption of a single audit program 
• Increased FDA stringency, especially around design, software, and materials or components, and supplier quality (FDA Quality System Regulation Part 820 and ISO 13485 and ISO 9001) and Current Good Manufacturing Practices (CGMPs) 
• ​Increases in Center for Device and Radiological Health (CDRH) inspections  

Ultimately, manufacturers are responsible for building the quality of the medical devices they produce. And that demands the ability to implement fully compliant supply chain.  

Improving Supply Chain Quality 

A highly effective way to track supply chain quality is to use a cloud-based enterprise quality management system (QMS) that can integrate end-to-end processes on one platform. For example, Sparta Systems’ TrackWise Digital Supplier QMS enables manufacturers to assess and evaluate suppliers to ensure that all partners in the production process are working to the same standards.  

Supplier quality management software provides a unified, centralized approach that meets best practices for evaluating and selecting suppliers, identifying nonconformance as soon as possible, implementing corrective actions, and evaluating each supplier’s performance, quality, and risk over time.  

Look for a solution that provides the following: 

• Supports automated data collection and reminders 
• Unifies rather than siloes quality data 
• Integrates with a wide range of ecosystems and operational systems and software 
• Provides robust reporting options 
• Offers site evaluation and user training 
• Provides a SaaS framework for anytime, anywhere access and easy scalability 

With a robust QMS that enables integration of and insight into supply chain quality, manufacturers gain one standardized digital system of process quality documentation and data. 

This enables organizations to reduce inaccuracies, inefficiencies, and delays. It can also simplify reporting and streamline response to audits.  

After all, outsourcing adds enough complexity. Shouldn’t your QMS help simplify things?